title: New paradigm for drug developments--from emerging market statistical perspective.
abstract: Paradigm for new drug development has changed dramatically over the last decade. Even though new technology increases efficiency in many aspects, partially due to much more stringent regulatory requirements, it actually now takes longer and costs more to develop a new drug. To deal with challenge, some initiatives are taken by the pharmaceutical industry. These initiatives include exploring emerging markets, conducting global trials and building research and development centers in emerging markets to curb spending. It is particularly the current trend that major pharmaceutical companies offshore a part of their biostatistical support to China. In this paper, we first discuss the skill set for trial statisticians in the new era. We then elaborate on some of the approaches for acquiring statistical talent and capacity in general, particularly in emerging markets. We also make some recommendations on the use of the PDUFA strategy and collaborations among industry, health authority and academia from emerging market statistical perspective.
authors.affiliation: Biostatistics and Programming, Sanofi, Bridgewater, NJ 08807, United States. Electronic address: hui.quan@sanofi.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Quan
authors.forename: Xun
authors.initials: X
authors.lastname: Chen
authors.forename: Ji
authors.initials: J
authors.lastname: Zhang
authors.forename: Peng-Liang
authors.initials: PL
authors.lastname: Zhao
mesh_terms: D002681:China; D003627:Data Interpretation, Statistical; D003906:Developing Countries; D017277:Drug Approval / Q000379:methods*; D004345:Drug Industry / Q000379:methods* / Q000458:organization & administration; D006801:Humans; D007391:International Cooperation; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D000078329:Workforce
keywords: Biostatistics talent; Clinical trial; Health authority; PDUFA; Pharmaceutical industry